Status:
TERMINATED
Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth fact...
Detailed Description
This is a single-arm, open-label, Phase 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI.
Eligibility Criteria
Inclusion
- Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
- At least 20 years of age at the time of signing informed consent.
- Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
- Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy.
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q).
- World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
- Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
- At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug.
- Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.
- Recovery to ≤ Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
Exclusion
- Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
- Previous treatment with anticancer therapies, EGFR-TKI (including erlotinib, gefitinib, and afatinib) within 8 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.
- Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
- Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
- History of any other malignancy
- Clinically significant uncontrolled condition(s)
- Active or chronic pancreatitis
- Anyone with cardiac abnormalities or history
- Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of radiation pneumonitis.
- Pregnant or breast feeding.
- In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713.
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04510415
Start Date
March 29 2018
End Date
December 11 2018
Last Update
August 12 2020
Active Locations (8)
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1
National Cancer Center
Gyeonggi-do, South Korea
2
The Catholic Univ. of Korea Bucheon St.Mary's Hospital
Gyeonggi-do, South Korea
3
The Catholic Univ. of Korea St.Vincent's Hospital
Gyeonggi-do, South Korea
4
The Catholic Univ. of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do, South Korea